510(k) · Cleared
ClearedDigital X-Ray Sensor, Model E9539,E9505,E9502, E9540
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba America Electronic Components, Inc. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Aug 27, 2009 as substantially equivalent to K950533 (Trophy Radiologie, 1995) and 2 other predicates after an 8-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it.
- Decided
- Aug 27, 2009
- Review
- 8 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K933455 (1994). 10 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK933455 Computed Oral Radiology SystemSchick Technologies, Inc. · 1994
- 2 generations backK022953 Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2002
- 1 generation backK072134 Schick Computed Oral Radiology SystemSchick Technologies, Inc. · 2007
- This deviceK092537 Digital X-Ray Sensor, Model E9539,E9505,E9502, E9540Toshiba America Electronic Components, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK110886 Clio/CliosoftSota Precision Optics, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK241495 Jazz ClassicJazz Imaging · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933455 | Computed Oral Radiology System | Schick Technologies, Inc. | 1994 | — |
| −2 | K022953 | Modification to Computed Oral Radiology System | Schick Technologies, Inc. | 2002 | — |
| −1 | K072134 | Schick Computed Oral Radiology System | Schick Technologies, Inc. | 2007 | — |
| 0 (this device) | K092537 | Digital X-Ray Sensor, Model E9539,E9505,E9502, E9540 | Toshiba America Electronic Components, Inc. | 2009 | — |
| +1 | K110886 | Clio/Cliosoft | Sota Precision Optics, Inc. | 2011 | — |
| +2 | K241495 | Jazz Classic | Jazz Imaging | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MUH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MUH device
- #1 K242778 X Sensor (Model: IOS-A15IF, HDI-15DGF)score 16.0 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K950533 | Trophy Radiologie RVG RadiovisiographySummary page 2…There are several major independent manufacturers of Intraoral Diagnostic Radiographic Systems on the US market. One is the Trophy Radiologie RVG. The 5 10(k) number is K950533. The classification of the Trophy Radiologie device is listed as product code EAP. The other currently marketed device is the Sc… | 1995 |
| * | K072134 | Schick Computed Oral Radiology SystemSummary page 2…classification of the Trophy Radiologie device is listed as product code EAP. The other currently marketed device is the Schick Technologies CDR. The 5 10(k) number is K072 1349. The classification of the Schick Technologies CDR is listed as product code MQB. And the other currently marketed device is th… | 2007 |
| * | K080738 | Dentron SensorSummary page 2…e Schick Technologies CDR is listed as product code MQB. And the other currently marketed device is the Video Dental Concepts, Inc. Dentron sensor The 5 10(k) number is K080738. The classification of the Video Dental Concepts, Inc. Dentron sensor is listed as product code MUH and MQB. In the comparison t… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110886 | Clio/Cliosoft | 2011 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K110886 (Sota Precision Optics, Inc., 2011) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K950533.
How does its category compare?
All MUH devicesMUH System, X-Ray, Extraoral Source, Digital: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MUH
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUH
159in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUH
1in 2025
MAUDE reports naming product code MUH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 48 | 0 | 0 |
| 2008 | 8 | 64 | 1 | 0 |
| 2009 | 9 | 88 | 2 | 12 |
| 2010 | 9 | 174 | 0 | 9 |
| 2011 | 10 | 89 | 0 | 0 |
| 2012 | 9 | 81 | 0 | 5 |
| 2013 | 9 | 172 | 1 | 1 |
| 2014 | 8 | 168 | 1 | 5 |
| 2015 | 12 | 111 | 1 | 3 |
| 2016 | 6 | 47 | 0 | 1 |
| 2017 | 9 | 84 | 0 | 4 |
| 2018 | 3 | 29 | 0 | 10 |
| 2019 | 5 | 64 | 0 | 6 |
| 2020 | 5 | 36 | 0 | 0 |
| 2021 | 10 | 80 | 0 | 1 |
| 2022 | 7 | 57 | 0 | 0 |
| 2023 | 11 | 57 | 0 | 1 |
| 2024 | 4 | 144 | 0 | 0 |
| 2025 | 3 | 159 | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Toshiba Digital X-ray Sensor is an intraoral receiver of X-ray energy by the dentist to obtain instant digital images of teeth and the oral cavity of patients. Images are transmitted to a computer for display.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092537 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092537: Digital X-Ray Sensor, Model E9539,E9505,E9502, E9540.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092537
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026